Associate Clinical Data Coder

Associate Clinical Data Coder #clinicalresearch #clinicaltrials #medicine #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #covid #biopharma #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #pharmaceuticalindustry #phd #oncology #drugdevelopment #cra #biotechnology The role of the Associate Clinical Data Coder ACDC is to perform assigned tasks or activities in clinical data coding. Activities may include coding of clinical data, generation, integration of queries, and running of reports under supervision of senior coding staff. All tasks should be performed in accordance to corporate quality standards, SOPsWork InstructionGuidelines, ICHGCP andor other international regulatory requirements. Clinical coding Perform the clinical coding mapping using coding dictionaries and map to the nearest Low Level TermLLT or Drug Name as the case may be. Identify the verbatim that are ambiguous and issue queries in line with applicable coding conventions.Provide work status updates regularly to direct supervisor or primary coder and sponsor Additionally, Provide inputs for process improvement Create Unique Terms ReportUTR Coding set up and documentation Assist in coding tool set up for the assigned trials Support in creation and central filing of clinical study documents which includes Coding conventions, coding definitions, coding configuration specification etc Dictionary management and Database lock Report any discrepancies observed with clinical dictionary used Report any issues with DBL process and related documentation. Additional responsibilities Assist with additional responsibilities as needed Compliance Comply with SOPs, manuals, trainings and best practices Compliance to ICHGCP. QualificationsBasic understanding of clinical trials methodology and terminology requiredBasic knowledge of medical terminologyKnowledge with Coding dictionaries e.g. MedDRA & WHODD preferredBachelor s degree and or other medical qualification or relevant coding or Data Management experience